Director - Regulatory Affairs - Award Winning CRO
With clinical activities growing rapidly, our client are currently seeking a full-time, office-based Sr. Director/Director, Regulatory Affairs to join our team.
- Work for multi award Winning CRO
- Work with a range of pharmaeceutical clients and innovative new drug launches
- Play key role in drug launches and getting patients products they need
- Various internal growth opportunities as company expands
- Generous compensation and benefits package
- Take key leadership role in growing team
- Opportunity to travel to global office locations
This position will lead OUS Regulatory Affairs and is accountable for the development and implementation of the regulatory strategy for specific Sponsor projects. Additionally, you'll be ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the team.
You must possesses strategic leadership skills, have deep experience in OUS regulatory science and overall drug/biologic development processes and strategies.
Experience and knowledge of therapeutic areas and drug development is an important enabler to being able to influence cross-functional discussions Sponsors and relevant stakeholders.
You'll be accountable for the development and implementation, at a regional or global level, of the regulatory strategy for a product / group of products, and for ensuring that the strategy is designed to deliver a rapid approval.
Additionally, strong man management skills are required as you lead the regulatory staff working on a product / project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
- Advanced degree required. Preferred degrees include, PharmD, MD, and/or PhD. Other degrees and backgrounds may be considered;
- >8 years of experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas;
- Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g. EMA, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.);
- Broad background of experience working in pharmaceutical business;
- Proven leadership and program management experience;
- Ability to think strategically and critically evaluate risks to regulatory activities;
- Ability to work strategically within a complex, business critical and high profile development program;
- Successful contribution to a major regulatory approval at a global or regional level;
- A scientific and clinical understanding of the regulatory sciences; and
- Must demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative, leadership, and excellent oral and written communication skills
Travel: Less than 10%.
For a confidential discussion about this, please contact Edward Little on 0207 940 2749 (EXT: 7168) or send your updated CV in a word document to E.Little@nonstop-recruitment.com
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
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